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Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome

Primary Purpose

Acute Respiratory Distress Syndrome

Status

Unknown status

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

HCR040 (Phase 1)

Placebo (Phase 2)

HCR040 (Phase 2)

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress Syndrome, mesenchymal stem cells, anti-inflammation, allogenic, ARDS, acute lung injury, cell therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women ≥ 18 years
Patients with criteria of moderate to severe ARDS according to the Berlin Conference.
Berlin criteria of moderate to severe ARDS given simultaneously during the 24 hours prior to entry into the study
Patients with invasive mechanical ventilation in controlled mode (VC, PC or VCRP) adjusted to Vt≤8 mL/kg, Ppl <30 cmH2O and minimum PEEP of 8 cmH2O

Exclusion Criteria:

Participation in a previous clinical study within 28 days prior to the ARDS situation
Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation
Inability to obtain Informed Consent
Hemodynamic instability that contraindicates the intravenous cellular administration, within the defined time frame for inclusion in the study
Alveolar hemorrhage or hemoptysis
LTSV situation (Limitation of life support treatments)
Major trauma in the previous 5 days
Neoplastic processes at any time
EPOC or severe home asthma or any other type of chronic respiratory disease requiring respiratory oxygen
Known Child-Pugh liver disease score > B9
Pregnant women or women of childbearing age who are not using an adequate method of contraception, or who, if they are using it, are not willing to continue using it for the duration of the trial. If the patient is menopausal or sterile, it must be documented in the medical record
Women who are breastfeeding if unwillingly to stop at the time of recruitment
Pulmonary transplant
Known grade III or IV pulmonary hypertension
States of hypercoagulability
History of DVP or PE in the last 6 months

Sites / Locations

Hospital Universitario de CrucesRecruiting
Fundación Jiménez Díaz

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

HCR040 (Phase 1)

Control group (Phase 2)

HCR040 (Phase 2)

Arm Description

Participants with moderate to severe acute respiratory distress syndrome (6 patients)

Participants with moderate to severe acute respiratory distress syndrome (10 patients)

Outcomes

Primary Outcome Measures

Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection

Secondary Outcome Measures

Average stay in the Intensive Care Unit (ICU) 28 days after the administration of HCR040

Sequential Organ Failure Assessment (SOFA) index at 3, 7, 14, 21, and 28 days after the administration of HCR040

SOFA index from 0 to 4 where lower scores represent improvement

Mechanical ventilation-free days 28 days after the administration of HCR040

Percent mortality 28 days after the administration of HCR040

Daily pulmonary mechanics values (Ppl, DP, CRS)

Determination of lung damage using the Murray scale at day 3, 7, 14 and 28 after the administration of HCR040

Murray scale from 0 to 4 where lower scores represent improvement

Vasopressor-free days 28 days after the administration of HCR040

ICU-free days 28 days after the administration of HCR040

Full Information

NCT ID

NCT04289194

First Posted

February 26, 2020

Last Updated

May 13, 2021

Sponsor

Histocell, S.L.

1. Study Identification

Unique Protocol Identification Number

NCT04289194

Brief Title

Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome

Official Title

Phase 1/2 Clinical Study to Assess the Feasibility, Safety, Tolerability and Preliminary Efficacy of the Administration of HCR040, Allogeneic Adipose-derived Adult Mesenchymal Stem Cells, in Acute Respiratory Distress Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Unknown status

Study Start Date

December 10, 2019 (Actual)

Primary Completion Date

August 15, 2021 (Anticipated)

Study Completion Date

April 16, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Histocell, S.L.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The main objective of the study is to assess the feasibility, safety, and tolerability of the administration of HCR040, a drug whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2, in patients with acute respiratory distress syndrome.

Detailed Description

HCR040 is an investigational medicinal product whose active substance is HC016, allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2. The main purpose of this study is to evaluate the safety and tolerability of a single administration of HCR040 using: a) two sequential escalating doses administered 96 hours post-injury to participants with moderate to severe acute respiratory distress syndrome (ARDS); and b) the determined maximum tolerated dose administered 96 hours post-injury to participants with moderate to severe ARDS. The study also includes initial exploration of efficacy. Treatment is administered by intravenous injection. The study has been divided into two phases: Phase 1 (open label): 6 participants with moderate to severe ARDS will be included in 2 sequential cohorts. Phase 2 (randomized, controlled, double-blind): 20 participants with moderate to severe ARDS will be randomly divided into two groups (control and treated).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Respiratory Distress Syndrome

Keywords

Acute Respiratory Distress Syndrome, mesenchymal stem cells, anti-inflammation, allogenic, ARDS, acute lung injury, cell therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HCR040 (Phase 1)

Arm Type

Experimental

Arm Description

Participants with moderate to severe acute respiratory distress syndrome (6 patients)

Arm Title

Control group (Phase 2)

Arm Type

Placebo Comparator

Arm Description

Participants with moderate to severe acute respiratory distress syndrome (10 patients)

Arm Title

HCR040 (Phase 2)

Arm Type

Experimental

Arm Description

Participants with moderate to severe acute respiratory distress syndrome (10 patients)

Intervention Type

Drug

Intervention Name(s)

HCR040 (Phase 1)

Other Intervention Name(s)

Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2

Intervention Description

(Phase 1) Intravenous administration. Open label dose escalation, 3 patients in cohort 1 (1 million cells/kg) and 3 patients in cohort 2 (2 million cells/kg)

Intervention Type

Drug

Intervention Name(s)

Placebo (Phase 2)

Other Intervention Name(s)

Saline solution

Intervention Description

(Phase 2) Intravenous administration of vehicle solution

Intervention Type

Drug

Intervention Name(s)

HCR040 (Phase 2)

Other Intervention Name(s)

Allogeneic adipose-derived adult mesenchymal stem cells expanded and pulsed with H2O2

Intervention Description

(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)

Primary Outcome Measure Information:

Title

Number of adverse events as a measure of safety and tolerability of a single dose of HCR040 when administered by intravenous injection

Time Frame

One year

Secondary Outcome Measure Information:

Title

Average stay in the Intensive Care Unit (ICU) 28 days after the administration of HCR040

Time Frame

Day 28

Title

Sequential Organ Failure Assessment (SOFA) index at 3, 7, 14, 21, and 28 days after the administration of HCR040

Description

SOFA index from 0 to 4 where lower scores represent improvement

Time Frame

Day 28

Title

Mechanical ventilation-free days 28 days after the administration of HCR040

Time Frame

Day 28

Title

Percent mortality 28 days after the administration of HCR040

Time Frame

Day 28

Title

Daily pulmonary mechanics values (Ppl, DP, CRS)

Time Frame

One year

Title

Determination of lung damage using the Murray scale at day 3, 7, 14 and 28 after the administration of HCR040

Description

Murray scale from 0 to 4 where lower scores represent improvement

Time Frame

Day 28

Title

Vasopressor-free days 28 days after the administration of HCR040

Time Frame

Day 28

Title

ICU-free days 28 days after the administration of HCR040

Time Frame

Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women ≥ 18 years Patients with criteria of moderate to severe ARDS according to the Berlin Conference. Berlin criteria of moderate to severe ARDS given simultaneously during the 24 hours prior to entry into the study Patients with invasive mechanical ventilation in controlled mode (VC, PC or VCRP) adjusted to Vt≤8 mL/kg, Ppl <30 cmH2O and minimum PEEP of 8 cmH2O Exclusion Criteria: Participation in a previous clinical study within 28 days prior to the ARDS situation Administration of a previous cell therapy product in the 5 years prior to this ARDS clinical situation Inability to obtain Informed Consent Hemodynamic instability that contraindicates the intravenous cellular administration, within the defined time frame for inclusion in the study Alveolar hemorrhage or hemoptysis LTSV situation (Limitation of life support treatments) Major trauma in the previous 5 days Neoplastic processes at any time EPOC or severe home asthma or any other type of chronic respiratory disease requiring respiratory oxygen Known Child-Pugh liver disease score > B9 Pregnant women or women of childbearing age who are not using an adequate method of contraception, or who, if they are using it, are not willing to continue using it for the duration of the trial. If the patient is menopausal or sterile, it must be documented in the medical record Women who are breastfeeding if unwillingly to stop at the time of recruitment Pulmonary transplant Known grade III or IV pulmonary hypertension States of hypercoagulability History of DVP or PE in the last 6 months

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Begoña Castro, PhD

Phone

+34 94 656 7900

bcastro@histocell.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fermin Labayen Beraza, MD

Organizational Affiliation

Hospital de Cruces

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Universitario de Cruces

City

Barakaldo

State/Province

Bizkaia

ZIP/Postal Code

48903

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fermin Labayen Beraza, MD

First Name & Middle Initial & Last Name & Degree

Fermin Labayen Beraza, MD

First Name & Middle Initial & Last Name & Degree

Pablo Serna, MD

First Name & Middle Initial & Last Name & Degree

Victoria Boado, MD

First Name & Middle Initial & Last Name & Degree

Tomás Muñoz, MD

Facility Name

Fundación Jiménez Díaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Individual Site Status

Completed

12. IPD Sharing Statement

Learn more about this trial

Clinical Study to Assess the Safety and Preliminary Efficacy of HCR040 in Acute Respiratory Distress Syndrome

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